CYSTOSCOPE 0/15/30/70 DEGREES

K960872 · Pollux Endoscopy, Inc. · FAJ · May 7, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K960872
• Device Name: CYSTOSCOPE 0/15/30/70 DEGREES
• Applicant: Pollux Endoscopy, Inc.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: May 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

This device is intended to provide access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals.

Device Story

Rigid cystoscope/resectoscope; provides access, illumination, and visualization of body cavities, hollow organs, and canals. Device features 354mm length; shaft diameters of 2.7mm (0/30/70 degree fields) and 4mm (0/15/30/70 degree fields). Used by physicians in clinical settings for endoscopic procedures. Operates via optical visualization; provides direct view to clinician for diagnostic or interventional decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to predicate.

Technological Characteristics

Rigid endoscope; 354mm length; 2.7mm and 4mm shaft diameters; 0/15/30/70 degree fields of view. Materials identical to predicate Sight-Plus Arthroscope.

Indications for Use

Indicated for visualization, observation, or manipulation of body cavities, hollow organs, and canals in patients requiring endoscopic examination.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Sight-Plus Arthroscope (K925226)

Submission Summary (Full Text)

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K960872

February 28, 1996

510(k) Summary

MAY - 7 1996

Submitter: Pollux Endoscopy, Inc.
Address: 4696 NW 103rd Avenue
Sunrise, FL 33351

Voice: [phone]
Contact: Precious Resch

Device: Cystoscope 0/15/30/70 degrees 2.7mm/4mm
Classification: Rigid Endoscope
Common/Usual Name: Rigid Cystoscope/Resectoscope

Name of device to which substantial equivalence is claimed:
Sight-Plus Arthroscope K925226

Intended Use: This device is intended to provide access, illumination and
allow observation or manipulation of body cavities, hollow
organs, and canals.

Description: This device has an overrall lenght of 354mm. This diameter of the
shaft is 2.7mm for direction of the center of field of view of 0/30/70
degrees. Diameter of the shaft of 4mm for direction of the center
of field of view of 0/15/30/70 degrees. This device is composed of
identical materials to that of the Sight-Plus Arthroscope.

"This summary of 510(k) safety and effectiveness information is being submitted
in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."